FDA's small business designation, officially a small business determination, cuts most device user fees by half to three quarters if your company and affiliates had $100 million or less in gross receipts or sales in their latest tax year. US companies apply with Form 3602N and a signed federal tax return, at least 60 days before paying a fee.
Key takeaways
- For fiscal year 2027, small business status cuts the 510(k) fee from $28,653 to $7,163, and the De Novo fee from $191,020 to $47,755.
- More than half of fee-paying 510(k)s used the small business rate in each of fiscal years 2023 to 2025, with 2,204 in 2025.
- A US company that has not yet filed a federal income tax return cannot qualify.
- Apply at least 60 days before the fee is due. Status ends every September 30, so you apply again each year.
- There is no small business discount on the annual establishment registration fee, which is $13,785 for fiscal year 2027.
What is FDA small business designation?
It is FDA's finding that your business qualifies for reduced or waived medical device user fees [1, 2]. FDA's official term is small business determination, often shortened to SBD; you will also see it called small business designation or small business status.
It comes with up to three benefits [2]:
| Benefit | Who qualifies |
|---|---|
| Reduced application fees | Gross receipts or sales of $100 million or less, including affiliates, in the most recent tax year |
| Waiver of the fee for your first premarket approval application | $30 million or less, and no earlier PMA, BLA, PDP or PMR from you or any affiliate. It does not cover a 510(k) |
| Waiver of the annual registration fee | $1 million or less, proof of financial hardship, and a registration fee paid in an earlier year |
For the registration fee waiver, FDA says the only situation it knows of that meets its hardship standard is active bankruptcy [2]. Our registration and listing guide covers the fee itself. Applying for small business status is free [2].
Who qualifies as a small business?
A business whose gross receipts or sales, together with all its affiliates, were $100 million or less in its most recent tax year [1, 2]. Three points trip people up:
- Affiliates count, worldwide. An affiliate is a business that controls yours, that you control, or that shares a controlling third party with you [1, 5]. Their gross receipts or sales are added to yours.
- It is gross receipts or sales, not net sales. FDA lists reporting net sales as a common error [6].
- Nonprofits are not automatically small. Tax-exempt organizations face the same threshold, and report the Total Revenue on line 12 of Form 990 [1].
How much does small business status save?
Half to three quarters of most fees. FDA's fees for fiscal year 2027, which runs from October 1, 2026 to September 30, 2027 [3, 4]:
| Submission | Standard fee | Small business fee |
|---|---|---|
| 510(k) | $28,653 | $7,163 |
| De Novo request | $191,020 | $47,755 |
| PMA | $636,732 | $159,183 |
| 513(g) request for classification information | $8,596 | $4,298 |
| 30-day notice | $10,188 | $5,094 |
Most 510(k) payers already use it. We analyzed FDA's own count of fee-paying submissions in its fiscal year 2027 fee notice [3]:
| Fiscal year | 510(k)s at the standard fee | 510(k)s at the small business fee | Small business share |
|---|---|---|---|
| 2023 | 1,943 | 2,031 | 51% |
| 2024 | 1,754 | 2,066 | 54% |
| 2025 | 1,883 | 2,204 | 54% |
We measured the share for De Novo requests too, and it is higher still: 49 of 62 fee-paying requests in fiscal year 2025, about 79% [3].
Complizen's free FDA fee calculator shows the small business saving for your submission. Our FDA user fees guide lists every fee, and our guide to what a 510(k) costs covers the costs beyond FDA's fee.
How do you get FDA small business designation?
Through FDA's CDRH Portal, in six steps [2, 6, 7]:
- Find your Organization ID (Org ID). It is assigned when you create a User Fee System account, and you will find it in your profile under Business Information. It is not your registration number, EIN, taxpayer ID or DUNS number.
- Gather your tax returns. You need your most recent federal income tax return, and one for each US affiliate [2]. Each foreign affiliate needs a certification from its national tax authority [2].
- Download and complete Form 3602N from FDA's forms page [8]. Enter the fiscal year you are applying for, list your own business on line 1 of Section II, and your affiliates from line 2 [6]. Use your full legal name, matching your tax return [7].
- Submit through the CDRH Portal. Choose "Create a Request", then "Small Business Determination request", and upload everything [2]. Since November 1, 2024, all small business requests must go through the Portal [9].
- Wait for FDA's decision. FDA aims to complete its review within 60 calendar days [2].
- Use your decision number. Enter your Small Business Decision number on the Medical Device User Fee Cover Sheet for each discounted submission [1, 2].
Your tax returns must be the real thing [2, 6]:
- signed and dated by an officer, partner or member of the company, in ink or with a valid digital signature
- free of watermarks such as "do not file", "client copy" or "taxpayer's copy"; copies e-filed with the IRS are acceptable
FDA says where it finds gross receipts or sales on each IRS form [6]:
| IRS form | Line |
|---|---|
| Schedule C (Form 1040) | 1 |
| Form 1065 or 1065-B | 1a |
| Form 1120 or 1120S | 1a |
| Form 1120-F | Section II, line 1a |
| Form 990 | 12 |
Headquartered outside the US? You prove your size with a certification from your national tax authority instead of a US tax return. Our guide to how foreign companies qualify covers that process.
When should you apply?
At least 60 days before you pay a fee, because the law requires it [1, 3]. FDA asks you to pay a 510(k) fee when you submit the 510(k), so apply at least 60 days before you plan to file [3].
- The window for fiscal year 2027 is open. In 2026, it opened on August 1, at 4:01 PM Eastern Time, and it runs to August 1, 2027 [2].
- Status starts on October 1 or the approval date, whichever is later, and ends on September 30 [2].
- You apply again every year. There is no backdating to a past fiscal year [1].
- Filing first costs you. If you submit an application before FDA qualifies you, you pay the full fee, and FDA does not refund the difference [1, 3].
Your 510(k) screening does not start until the fee is paid, as our FDA RTA checklist explains.
Which mistakes get a request denied?
We reviewed FDA's training module on common submission errors, published in August 2026. FDA says it cannot add missing information or correct your request for you, and that missing information and documents may lead to denial [6]. The common errors FDA lists:
- A wrong Org ID. FDA calls this the most common error [6].
- A wrong or missing fiscal year at the top of Form 3602N [6].
- Leaving your own business off Section II. It belongs on line 1 [6].
- Incomplete tax returns: unsigned, undated or watermarked copies [6].
- Net sales instead of gross receipts or sales [6].
Two more cost companies the discount:
- Applying before your first tax return. A US business cannot qualify until it has submitted a federal income tax return [2].
- Letting a consultant apply in its own name. The business that pays the fee and appears as the applicant must hold the determination [2].
Frequently asked questions
What is FDA small business designation?
It is the common name for FDA's small business determination, which qualifies a business for reduced or waived medical device user fees. A business qualifies if its gross receipts or sales, including all affiliates, were $100 million or less in its most recent tax year.
Is small business designation the same as small business determination?
Yes. FDA's official term is small business determination, or SBD, and the request you submit is a Small Business Request, or SBR. FDA also calls it small business status; small business designation is an informal name for the same thing. The form is Form FDA 3602N.
How much does FDA small business status save on a 510(k)?
For fiscal year 2027, the standard 510(k) fee is $28,653 and the small business fee is $7,163, a saving of $21,490. De Novo requests fall from $191,020 to $47,755, and PMAs from $636,732 to $159,183. More than half of fee-paying 510(k)s used the small business rate in fiscal year 2025.
How long does FDA take to approve small business status?
FDA aims to complete its review within 60 calendar days of receiving your request. The law also requires your request at least 60 days before the fee is due, so apply well before you plan to submit your 510(k). Status then starts on October 1 or the approval date, whichever is later.
Can a new company qualify as an FDA small business?
A US company cannot qualify until it has submitted a federal income tax return, because FDA needs the most recent return to confirm your gross receipts or sales. If your company is new, plan your first return before your first fee-paying submission.
Do affiliates count toward the $100 million limit?
Yes. Every business that controls yours, that you control, or that shares a controlling third party with you counts, wherever it is. Their gross receipts or sales are added to yours. Each US affiliate needs its most recent federal tax return.
Where on my tax return does FDA look for gross receipts?
FDA lists line 1 of Schedule C (Form 1040), line 1a of Forms 1065, 1065-B, 1120 and 1120S, line 1a of Section II of Form 1120-F, and line 12 of Form 990. Report gross receipts or sales, not net sales.
Why was my small business request denied?
FDA's list of common errors includes a wrong Org ID, which it calls the most common, a wrong or missing fiscal year, leaving your own business off Section II, incomplete or watermarked tax returns, and reporting net sales. FDA cannot correct your request for you, so check everything before you submit.
Does small business status reduce the FDA registration fee?
No. The annual establishment registration fee is $13,785 for fiscal year 2027, with no small business rate. A business with $1 million or less in gross receipts may request a hardship waiver, but FDA says the only qualifying situation it knows of is active bankruptcy.
Do I need to reapply every year?
Yes. Small business status ends on September 30, the end of FDA's fiscal year. The request window for the next fiscal year opens in August, so you can apply before your current status runs out. FDA cannot grant status for a past fiscal year.
Can a nonprofit or university qualify as a small business?
Yes, if its revenue is $100 million or less, but it is not automatically small because it is tax-exempt. FDA asks tax-exempt organizations to report Total Revenue from line 12 of Form 990, and to include a signed copy of the form.
What if I already paid the full fee?
FDA will not refund the difference if you qualify after submitting. If you submit an application before FDA qualifies you as a small business, you must pay the standard fee. Wait for your small business decision before you file your next submission.
References
- FDA. Medical Device User Fee Small Business Qualification and Determination. Guidance issued July 31, 2025.
- FDA. Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program. Content current as of September 21, 2026.
- Federal Register. Medical Device User Fee Rates for Fiscal Year 2027, 91 FR 48134, including Table 3. Published July 30, 2026.
- FDA. Medical Device User Fee Amendments (MDUFA). Content current as of July 30, 2026.
- US Code. 21 U.S.C. 379i, definition of "affiliate". Accessed October 1, 2026.
- FDA. Small Business Determination Program: Common Submission Errors. CDRH Learn module, August 2026.
- FDA. Small Business Determination Program: Form 3602N, Section I. CDRH Learn module, 2026.
- FDA. Forms, including Form FDA 3602N. Accessed October 1, 2026.
- FDA. Send and Track Medical Device Premarket Submissions Online: CDRH Portal. Content current as of December 5, 2025.